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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000043932
Ethics application status
Approved
Date submitted
11/01/2011
Date registered
13/01/2011
Date last updated
13/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
C-reactive protein response to newborn hepatitis B immunisation
Scientific title
C-reactive protein response to newborn hepatitis B immunisation
Secondary ID [1] 253391 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Concentration of C-reactive protein in blood after hepatitis B immunisation 260945 0
Condition category
Condition code
Inflammatory and Immune System 259079 259079 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Term babies born by elective caesarean section are randomised to recieve routine intramuscular monovalent hepatitis B immunisation (0.5mL of H-B-Vax II, CSL Biotherapies/Merck & Co Inc, containing 5 micrograms of hepatitis B surface antigen adsorbed onto 0.25 mg of aluminium hydroxide in 0.5 mL) either at 24 or after 96 hours of age. Daily CRP levels are taken at 24, 48, 72 and 96 hours. Administration of vaccine at either 24 or 96 hours is within standard practice.
Intervention code [1] 257836 0
Early detection / Screening
Comparator / control treatment
All babies recieve standard treatment, namely immunisation with monovalent hepatitis B vaccine within the first week of life. In one group (the control group) vaccine is given slightly later. The comparison is the effect on CRP concentrations between normal dose and no dose of hepatitis B vaccine in the first 96 hours of life.
Control group
Active

Outcomes
Primary outcome [1] 259935 0
Concentration of CRP in blood
Timepoint [1] 259935 0
CRP concentrations measured at 24, 48, 72 and 96 hours of life
Secondary outcome [1] 268842 0
Nil
Timepoint [1] 268842 0
Nil

Eligibility
Key inclusion criteria
Gestation 37-40 weeks
Elective caesarean section without labour or membrane rupture
Well at 24 hours of age
Parental intention to give birth dose of hepatitis B vaccine
Minimum age
24 Hours
Maximum age
24 Hours
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Gestation <37 weeks or >40 weeks
Unwell at 24 hours of age
Parents don't intend to give birth dose of hepatitis B vaccine

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
At 24 hours of age, babies were randomised to a treatment group by opening sequentially numbered opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation sequence was developed before the start of the study by placing a single slip of paper labelled either Immunisation or Control (6 slips, 3 of each treatment, block length 6) into each of 6 identical opaque envelopes, sealing the envelopes, shuffling and then numbering the envelopes sequentially. The process was repeated in blocks of 6 until the required total number of envelopes (40 envelopes numbered 1-40) was assembled.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258307 0
Hospital
Name [1] 258307 0
Flinders Medical Centre
Address [1] 258307 0
Flinders Drive
Bedford Park
South Australia
5042
Country [1] 258307 0
Australia
Funding source category [2] 258308 0
Hospital
Name [2] 258308 0
Canberra Hospital
Address [2] 258308 0
Yamba Drive
Garran
ACT
2605
Country [2] 258308 0
Australia
Primary sponsor type
Individual
Name
Scott Morris
Address
Centre for Perinatal medicine
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia
5042
Country
Australia
Secondary sponsor category [1] 257472 0
None
Name [1] 257472 0
Address [1] 257472 0
Country [1] 257472 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260296 0
ACT Health and Community Care Human research Ethics Committee
Ethics committee address [1] 260296 0
GPO Box 825
Canberra
ACT
2601
Ethics committee country [1] 260296 0
Australia
Date submitted for ethics approval [1] 260296 0
Approval date [1] 260296 0
15/10/2001
Ethics approval number [1] 260296 0
ETH.9/01.323
Ethics committee name [2] 260300 0
Southern Adelaide Health Service/Flinders University Human Research Ethics committee
Ethics committee address [2] 260300 0
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia
5042
Ethics committee country [2] 260300 0
Australia
Date submitted for ethics approval [2] 260300 0
Approval date [2] 260300 0
25/03/2002
Ethics approval number [2] 260300 0
30/02

Summary
Brief summary
CRP may be useful in the newborn period as an infection screen. Universal hepatitis B immunisation may limit the usefulness of CRP if an inflammatory response is induced. This study looks at CRP response after birth in a group of babies where infection can definitely be excluded. Babies are randomised to recieve vaccination at either 24 hours of age or after 96 hours. A CRP level is taken each day and the levels in the 2 groups are compared.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 32082 0
Address 32082 0
Country 32082 0
Phone 32082 0
Fax 32082 0
Email 32082 0
Contact person for public queries
Name 15329 0
Scott Morris
Address 15329 0
Centre for Perinatal Medicine
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia
5042
Country 15329 0
Australia
Phone 15329 0
618 82044595
Fax 15329 0
618 82043143
Email 15329 0
scott.morris@health.sa.gov.au
Contact person for scientific queries
Name 6257 0
Scott Morris
Address 6257 0
Centre for Perinatal Medicine
Flinders Medical Centre
Bedford Park
South Australia
5042
Country 6257 0
Australia
Phone 6257 0
618 82044595
Fax 6257 0
618 82043143
Email 6257 0
scott.morris@health.sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary